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To apply for Class D medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you must follow a structured online process through the Medical Device Division (MDD). Class D represents the highest-risk category, so the application process is rigorous.
Here’s a complete guide on how and where to apply:
📝 Step-by-Step: How to Apply for Class D MDACS Registration in Hong Kong
✅ Step 1: Confirm Device Classification as Class D
Refer to:
TR-003 for general medical devices
TR-006 for in vitro diagnostic (IVD) devices
Class D includes:
Devices that are life-sustaining, implantable, or in direct contact with the heart/CNS
High-risk IVDs (e.g., HIV diagnostics, blood grouping tests)
✅ Step 2: Appoint a Local Responsible Person (LRP)
If the manufacturer is not based in Hong Kong, you must appoint a Local Responsible Person (LRP).
The LRP must be:
A registered business in Hong Kong
Responsible for submission, post-market surveillance, and communication with MDD
LRP registers for an MDIS account (Medical Device Information System)
✅ Step 3: Prepare Required Documentation
You must compile a complete technical dossier for Class D. Required documents include:
| Document | Description |
|---|---|
| MDACS Application Form | MD-1 form submitted online |
| Declaration of Conformity | Per Essential Principles (GN-01 or GN-02) |
| Foreign Regulatory Approval | CE, FDA, TGA, NMPA, or similar |
| ISO 13485 Certificate | For manufacturer’s QMS |
| Clinical Evaluation Report (CER) | Based on trials or literature |
| Risk Management Report | Based on ISO 14971 |
| Labeling and IFU | In English and/or Traditional Chinese |
| Post-Market Surveillance Plan | Including AE reporting and recall handling |
| Technical File Summary | Design, materials, specifications |
| Test Reports | Sterilization, biocompatibility, EMC/safety (if applicable) |
✅ Step 4: Submit Application via MDIS Portal
🔹 Where to Apply:
Medical Device Information System (MDIS)
→ https://www.mdd.gov.hk/en/mdacs/mdis/index.html
🔹 How to Apply:
LRP logs in to the MDIS portal.
Select “Device Listing Application” and input:
Device model, description, intended use, classification
Upload all required PDF documents
Submit the form electronically
✅ Note: Since April 2024, paper submissions are no longer accepted.
✅ Step 5: Respond to MDD Review
MDD will screen and review the application.
They may request additional documents or clarifications.
LRP must reply via MDIS within specified deadlines.
✅ Step 6: Listing Approval
Upon successful review, the device will be:
Listed in the MDACS database
Issued a device listing certificate
Listing is valid for 5 years (renewable)
📍 Where is MDACS Registration Handled?
| Item | Details |
|---|---|
| Responsible Authority | Medical Device Division (MDD), Department of Health, Hong Kong |
| Submission Platform | MDIS (Medical Device Information System) |
| Official Website | https://www.mdd.gov.hk |
| Physical Address (for reference only) | Room 3101, 31/F, Hopewell Centre, 183 Queen’s Road East, Wan Chai, Hong Kong |
| mdd@dh.gov.hk | |
| Phone | +852 3107 8484 |
❗ Important: All applications must be handled online via MDIS; do not send paper forms or visit in person for submissions.
🕒 Timeline
| Stage | Estimated Time |
|---|---|
| Document preparation | 1–3 months |
| MDD review | 3–6 months (may vary) |
| Total duration | ~4–9 months depending on completeness |
✅ Summary: How & Where to Apply
| Task | Details |
|---|---|
| Where to apply | MDIS portal |
| Who can apply | Only through a Hong Kong-based Local Responsible Person (LRP) |
| Submission method | 100% online (no paper forms accepted) |
| Handled by | Medical Device Division (MDD), Hong Kong DoH |
| Device listing validity | 5 years |
Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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